March 23, 2020
As we start Week 2 of our “new normal” with the coronavirus pandemic, the Lupus Research Alliance continues to watch rapidly changing developments regarding COVID-19 closely. We are working on your behalf with the federal government and healthcare agencies, and we promise to bring you important and relevant updates.
First of all, your safety is our biggest concern. Living with lupus, you are already a pro at doing what you can to avoid contact with people who are sick. Now’s the time to double-up on your usual precautions and follow the recommendations of the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) by washing hands often for at least 20 seconds, keeping at least six feet away from others, avoiding crowds, and if you or others around you are sick, wearing a mask. Please visit our FAQ for more information.
Thrust into the spotlight this week was news about the potential benefit of anti-malarial drugs hydroxychloroquine (brand name Plaquenil) and chloroquine in treating COVID-19. As you know, Plaquenil is the most commonly used drug for lupus. Anecdotal evidence from small studies suggests that these drugs may reduce symptoms of COVID-19 and even slow down replication of the virus. Even though these drugs are not officially approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, physicians are using Plaquenil on an “off-label” basis in patients with COVID-19.
Given this extraordinary development, shortages of Plaquenil are developing. In some pharmacies, especially in New York and California, the drug has been unavailable. Although it is unclear how pervasive shortages might become, the Lupus Research Alliance and other organizations in rheumatology have urged the U.S. FDA to address the shortages and over the past few days we have seen some good news:
- The World Health Organization announced a global “Solidarity Trial” to test which drugs, including chloroquine, may be most effective against the virus.
- The U.S. Food and Drug Administration responded to pleas from the Lupus Research Alliance and other organizations as well as the White House with an encouraging statement from FDA Commissioner Stephen Hahn, M.D. underscoring that the FDA is working quickly to enable the rapid testing of hydroxychloroquine in patients with COVID-19 while engaging with U.S. manufacturers to ramp up its production to mitigate potential shortages. Dr. Hahn added, “We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”
Literally overnight, the pharmaceutical industry responded with important donations to ensure adequate supply:
- Novartis committed to donate up to 130 million doses of hydroxychloroquine by end of May and is supporting ongoing clinical trial efforts to evaluate hydroxychloroquine and chloroquine in treating COVID-19. The company is also exploring scaling up its ability to increase supply to ensure patients currently depending on this medicine are not impacted by the situation.
- Mylan N.V. started producing hydroxychloroquine tablets at its U.S. manufacturing facility and initiated production outside of the U.S. The company expects to ramp up manufacturing to provide 50 million tablets by mid-April.
- Similarly, Teva said production is ramping up and that it will donate 6+ million doses of hydroxychloroquine sulfate tablets to hospitals across the U.S.
- Bayer announced it is joining the U.S. government to fight against COVID-19 with a donation of 3 million tablets of their malaria drug Resochin, the brand name for chloroquine phosphate. Currently, Resochin is not approved for use in the U.S. but Bayer is working with appropriate agencies to secure an Emergency Use Authorization for the drug’s use in the U.S.
The Lupus Research Alliance will continue to monitor the situation closely to ensure shortages abate in the future.
Several other companies announced the start of clinical trials on existing rheumatoid arthritis drugs to test their safety and effectiveness in COVID-19:
- Genentech announced this week it is launching a Phase III trial to assess its marketed drug Actemra® (tocilizumab) as a treatment for adults with severe COVID-19 pneumonia.
- Regeneron Pharmaceuticals, Inc. and Sanofi initiated clinical trials of their Kevzara® (sarilumab) for the treatment for severe symptoms of COVID-19.
It is our hope that these measures and others will ensure that lupus patients are able to continue with their regular therapies. We at the Lupus Research Alliance will continue to push for access to the medications you need. As with all medication concerns, please speak with your rheumatologist or caring physician.
I’d like to end on a personal note. This is undoubtedly a stressful time. Practicing self-care and keeping positive is critical right now. Our Chief Administrative Officer Debra Rose has been sharing daily uplifting quotes to keep our staff positive. One of my favorites is:
“Helping others, encouraging others, are often acts of being kind that have more meaning than you may realize.” Catherine Pulsifer
Another way to gain inspiration and give hope to others is to visit our Community Forum.
The coming weeks are sure to bring other developments. We will do everything we can to bring you the latest news and advocate for our lupus community. Meanwhile, take good care, stay calm — and stay healthy!
Kenneth M. Farber
President & CEO
Lupus Research Alliance